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NOT YET RECRUITING
NCT07808645
NA

Wearable Sleep EEG and Auditory Stimulation in Healthy Adults

Sponsor: University of Houston

View on ClinicalTrials.gov

Summary

The purpose of this single-site pilot study is to evaluate the feasibility, usability, and technical performance of a wearable sleep-monitoring system that records electroencephalography (EEG) and delivers brief, low-volume sounds during selected stages of sleep. Approximately 30 healthy adults aged 18 to 30 years will use the system at home for up to 12 weeks, with a target of at least 15 usable nights of sleep recording. Participants will also complete smartphone-based assessments of sleep, mood, stress, device experience, and memory. The study will evaluate home-use completion, EEG signal quality, automated sleep-stage detection, delivery of auditory stimulation, participant adherence, and safety and tolerability. This pilot study is intended to refine the device and study procedures and is not designed to determine whether the system treats depression or another medical condition.

Official title: Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-04-01

Completion Date

2028-06-30

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

DEVICE

Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System

An investigational, external, battery-powered, non-invasive forehead-worn system that records EEG during sleep, supports automated sleep-stage and slow-wave detection, and delivers brief, low-volume pink-noise sounds during selected stages of non-rapid eye movement sleep according to study-configured closed-loop timing parameters. The system does not deliver electrical stimulation to the participant. Device and stimulation settings are configured by study personnel.